Clinical question: Can intervention by pharmacists and physicians improve compliance to cardio-protective medications?

Background: Adherence to cardio-protective medications in the year after hospitalization for acute coronary syndrome is poor.

Study design: RCT.

Setting: Four Department of Veterans Affairs medical centers.

Synopsis: The intervention consisted of pharmacist-led medication reconciliation, patient education, pharmacist and PCP +/- cardiologist collaboration, and voice messaging. The outcome measured was the proportion of patients adherent to medication regimens based on a mean proportion of days covered (PDC) >0.80 in the year after discharge, using pharmacy refill data for clopidogrel, beta blockers, statins, and ACEI/ARBs.

Two hundred forty-one patients (95.3%) completed the study. In the intervention group, 89.3% of patients were adherent vs. 73.9% in the usual care group (P=0.003). Mean PDC was higher in the intervention group (0.94 vs. 0.87; P<0.001). A greater proportion of intervention patients were adherent to clopidogrel (86.8% vs. 70.7%; P=0.03), statins (93.2% vs. 71.3%; P<0.001), and ACEI/ARBs (93.1% vs. 81.7%; P=0.03), but not beta blockers (88.1% vs. 84.8%; P=0.59). There were no statistically significant differences in the proportion of patients who achieved blood pressure and LDL-C level goals.

Bottom line: An interdisciplinary, multi-faceted intervention increased medication compliance in the year after discharge for ACS but did not improve blood pressure or LDL-C levels.

Citation: Ho PM, Lambert-Kerzner A, Carey EP, et al. Multifaceted intervention to improve medication adherence and secondary prevention measures after acute coronary syndrome hospital discharge. JAMA Intern Med. 2014;174(2):186-193.

Clinical question: Can intervention by pharmacists and physicians improve compliance to cardio-protective medications?

Background: Adherence to cardio-protective medications in the year after hospitalization for acute coronary syndrome is poor.

Study design: RCT.

Setting: Four Department of Veterans Affairs medical centers.

Synopsis: The intervention consisted of pharmacist-led medication reconciliation, patient education, pharmacist and PCP +/- cardiologist collaboration, and voice messaging. The outcome measured was the proportion of patients adherent to medication regimens based on a mean proportion of days covered (PDC) >0.80 in the year after discharge, using pharmacy refill data for clopidogrel, beta blockers, statins, and ACEI/ARBs.

Two hundred forty-one patients (95.3%) completed the study. In the intervention group, 89.3% of patients were adherent vs. 73.9% in the usual care group (P=0.003). Mean PDC was higher in the intervention group (0.94 vs. 0.87; P<0.001). A greater proportion of intervention patients were adherent to clopidogrel (86.8% vs. 70.7%; P=0.03), statins (93.2% vs. 71.3%; P<0.001), and ACEI/ARBs (93.1% vs. 81.7%; P=0.03), but not beta blockers (88.1% vs. 84.8%; P=0.59). There were no statistically significant differences in the proportion of patients who achieved blood pressure and LDL-C level goals.

Bottom line: An interdisciplinary, multi-faceted intervention increased medication compliance in the year after discharge for ACS but did not improve blood pressure or LDL-C levels.

Citation: Ho PM, Lambert-Kerzner A, Carey EP, et al. Multifaceted intervention to improve medication adherence and secondary prevention measures after acute coronary syndrome hospital discharge. JAMA Intern Med. 2014;174(2):186-193.

Clinical question: Can intervention by pharmacists and physicians improve compliance to cardio-protective medications?

Background: Adherence to cardio-protective medications in the year after hospitalization for acute coronary syndrome is poor.

Study design: RCT.

Setting: Four Department of Veterans Affairs medical centers.

Synopsis: The intervention consisted of pharmacist-led medication reconciliation, patient education, pharmacist and PCP +/- cardiologist collaboration, and voice messaging. The outcome measured was the proportion of patients adherent to medication regimens based on a mean proportion of days covered (PDC) >0.80 in the year after discharge, using pharmacy refill data for clopidogrel, beta blockers, statins, and ACEI/ARBs.

Two hundred forty-one patients (95.3%) completed the study. In the intervention group, 89.3% of patients were adherent vs. 73.9% in the usual care group (P=0.003). Mean PDC was higher in the intervention group (0.94 vs. 0.87; P<0.001). A greater proportion of intervention patients were adherent to clopidogrel (86.8% vs. 70.7%; P=0.03), statins (93.2% vs. 71.3%; P<0.001), and ACEI/ARBs (93.1% vs. 81.7%; P=0.03), but not beta blockers (88.1% vs. 84.8%; P=0.59). There were no statistically significant differences in the proportion of patients who achieved blood pressure and LDL-C level goals.

Bottom line: An interdisciplinary, multi-faceted intervention increased medication compliance in the year after discharge for ACS but did not improve blood pressure or LDL-C levels.

Citation: Ho PM, Lambert-Kerzner A, Carey EP, et al. Multifaceted intervention to improve medication adherence and secondary prevention measures after acute coronary syndrome hospital discharge. JAMA Intern Med. 2014;174(2):186-193.

Background: After initial infection, 10%–25% of patients experience recurrent CDI. The identification of patients at high risk of recurrence would be beneficial for therapeutic decision-making.

Study design: Retrospective cohort study.

Setting: Large, urban, academic medical center.

Synopsis: Authors included 4,196 patients with an initial infection defined by a positive C. diff toxin assay and unformed stools. A repeat positive toxin within 42 days of completing treatment for the initial infection represented recurrent CDI. Multiple characteristics were examined to identify risks of recurrent infection, including demographics and those related to acute and chronic disease. A logistic regression model was used to identify risk factors for recurrence. Recurrent CDI occurred in 425 patients (10.1%). Age, fluoroquinolone and high-risk antibiotic use, community-acquired healthcare-associated infection, multiple hospitalizations, and gastric acid suppression were found to predict recurrent infection through multivariate analysis. Limitations of the study included potential confounding, use of observational data, and generalizability given the urban academic medical center setting. This prediction model differs from previously developed models in that it identifies factors present at the onset of infection.

Bottom line: Multiple factors identified at the onset of illness can predict CDI recurrence.

Citation: Zilberberg MD, Reske K, Olsen M, Yan Y, Dubberke ER. Development and validation of a recurrent Clostridium difficile risk-prediction model. J Hosp Med. 2014;9(7):418-423. TH

Background: After initial infection, 10%–25% of patients experience recurrent CDI. The identification of patients at high risk of recurrence would be beneficial for therapeutic decision-making.

Study design: Retrospective cohort study.

Setting: Large, urban, academic medical center.

Synopsis: Authors included 4,196 patients with an initial infection defined by a positive C. diff toxin assay and unformed stools. A repeat positive toxin within 42 days of completing treatment for the initial infection represented recurrent CDI. Multiple characteristics were examined to identify risks of recurrent infection, including demographics and those related to acute and chronic disease. A logistic regression model was used to identify risk factors for recurrence. Recurrent CDI occurred in 425 patients (10.1%). Age, fluoroquinolone and high-risk antibiotic use, community-acquired healthcare-associated infection, multiple hospitalizations, and gastric acid suppression were found to predict recurrent infection through multivariate analysis. Limitations of the study included potential confounding, use of observational data, and generalizability given the urban academic medical center setting. This prediction model differs from previously developed models in that it identifies factors present at the onset of infection.

Bottom line: Multiple factors identified at the onset of illness can predict CDI recurrence.

Citation: Zilberberg MD, Reske K, Olsen M, Yan Y, Dubberke ER. Development and validation of a recurrent Clostridium difficile risk-prediction model. J Hosp Med. 2014;9(7):418-423. TH

Background: After initial infection, 10%–25% of patients experience recurrent CDI. The identification of patients at high risk of recurrence would be beneficial for therapeutic decision-making.

Study design: Retrospective cohort study.

Setting: Large, urban, academic medical center.

Synopsis: Authors included 4,196 patients with an initial infection defined by a positive C. diff toxin assay and unformed stools. A repeat positive toxin within 42 days of completing treatment for the initial infection represented recurrent CDI. Multiple characteristics were examined to identify risks of recurrent infection, including demographics and those related to acute and chronic disease. A logistic regression model was used to identify risk factors for recurrence. Recurrent CDI occurred in 425 patients (10.1%). Age, fluoroquinolone and high-risk antibiotic use, community-acquired healthcare-associated infection, multiple hospitalizations, and gastric acid suppression were found to predict recurrent infection through multivariate analysis. Limitations of the study included potential confounding, use of observational data, and generalizability given the urban academic medical center setting. This prediction model differs from previously developed models in that it identifies factors present at the onset of infection.

Bottom line: Multiple factors identified at the onset of illness can predict CDI recurrence.

Citation: Zilberberg MD, Reske K, Olsen M, Yan Y, Dubberke ER. Development and validation of a recurrent Clostridium difficile risk-prediction model. J Hosp Med. 2014;9(7):418-423. TH

Clinical question: In critically ill patients admitted to the ICU with hypovolemic shock, does the use of colloid for fluid resuscitation, compared with crystalloid, improve mortality?

Background: The current Surviving Sepsis Campaign guidelines recommend crystalloids as the preferred fluid for resuscitation of patients with hypovolemic shock; however, evidence supporting the choice of intravenous colloid vs. crystalloid solutions for management of hypovolemic shock is weak.

Study design: RCT.

Setting: International, multi-center study.

Synopsis: Researchers randomized 2,857 adult patients who were admitted to an ICU and required fluid resuscitation for acute hypovolemia to receive either crystalloids or colloids.

At 28 days, there were 359 deaths (25.4%) in the colloids group vs. 390 deaths (27.0%) in the crystalloids group (P=0.26). At 90 days, there were 434 deaths (30.7%) in the colloids group vs. 493 deaths (34.2%) in the crystalloids group (P=0.03).

Renal replacement therapy was used in 11.0% of the colloids group vs. 12.5% of the crystalloids group (P=0.19). There were more days alive without mechanical ventilation in the colloids group vs. the crystalloids group at seven days (P=0.01) and at 28 days (P=0.01), and there were more days alive without vasopressor therapy in the colloids group vs. the crystalloids group at seven days (P=0.04) and at 28 days (P=0.03).

Major limitations of the study included the use of open-labeled fluids during allocation, so the initial investigators were not blinded to the type of fluid. Moreover, the study compared two therapeutic strategies (colloid vs. crystalloids) rather than two types of molecules.

Bottom line: In ICU patients with hypovolemia requiring resuscitation, the use of colloids vs. crystalloids did not result in a significant difference in 28-day mortality; however, 90-day mortality was lower among patients receiving colloids.

Citation: Annane D, Siami S, Jaber S, et al. Effects of fluid resuscitation with colloids vs crystalloids on mortality of critically ill patients presenting with hypovolemic shock: the CRISTAL randomization trial. JAMA. 2013;310(17):1809-1817

Clinical question: In critically ill patients admitted to the ICU with hypovolemic shock, does the use of colloid for fluid resuscitation, compared with crystalloid, improve mortality?

Background: The current Surviving Sepsis Campaign guidelines recommend crystalloids as the preferred fluid for resuscitation of patients with hypovolemic shock; however, evidence supporting the choice of intravenous colloid vs. crystalloid solutions for management of hypovolemic shock is weak.

Study design: RCT.

Setting: International, multi-center study.

Synopsis: Researchers randomized 2,857 adult patients who were admitted to an ICU and required fluid resuscitation for acute hypovolemia to receive either crystalloids or colloids.

At 28 days, there were 359 deaths (25.4%) in the colloids group vs. 390 deaths (27.0%) in the crystalloids group (P=0.26). At 90 days, there were 434 deaths (30.7%) in the colloids group vs. 493 deaths (34.2%) in the crystalloids group (P=0.03).

Renal replacement therapy was used in 11.0% of the colloids group vs. 12.5% of the crystalloids group (P=0.19). There were more days alive without mechanical ventilation in the colloids group vs. the crystalloids group at seven days (P=0.01) and at 28 days (P=0.01), and there were more days alive without vasopressor therapy in the colloids group vs. the crystalloids group at seven days (P=0.04) and at 28 days (P=0.03).

Major limitations of the study included the use of open-labeled fluids during allocation, so the initial investigators were not blinded to the type of fluid. Moreover, the study compared two therapeutic strategies (colloid vs. crystalloids) rather than two types of molecules.

Bottom line: In ICU patients with hypovolemia requiring resuscitation, the use of colloids vs. crystalloids did not result in a significant difference in 28-day mortality; however, 90-day mortality was lower among patients receiving colloids.

Citation: Annane D, Siami S, Jaber S, et al. Effects of fluid resuscitation with colloids vs crystalloids on mortality of critically ill patients presenting with hypovolemic shock: the CRISTAL randomization trial. JAMA. 2013;310(17):1809-1817

Clinical question: In critically ill patients admitted to the ICU with hypovolemic shock, does the use of colloid for fluid resuscitation, compared with crystalloid, improve mortality?

Background: The current Surviving Sepsis Campaign guidelines recommend crystalloids as the preferred fluid for resuscitation of patients with hypovolemic shock; however, evidence supporting the choice of intravenous colloid vs. crystalloid solutions for management of hypovolemic shock is weak.

Study design: RCT.

Setting: International, multi-center study.

Synopsis: Researchers randomized 2,857 adult patients who were admitted to an ICU and required fluid resuscitation for acute hypovolemia to receive either crystalloids or colloids.

At 28 days, there were 359 deaths (25.4%) in the colloids group vs. 390 deaths (27.0%) in the crystalloids group (P=0.26). At 90 days, there were 434 deaths (30.7%) in the colloids group vs. 493 deaths (34.2%) in the crystalloids group (P=0.03).

Renal replacement therapy was used in 11.0% of the colloids group vs. 12.5% of the crystalloids group (P=0.19). There were more days alive without mechanical ventilation in the colloids group vs. the crystalloids group at seven days (P=0.01) and at 28 days (P=0.01), and there were more days alive without vasopressor therapy in the colloids group vs. the crystalloids group at seven days (P=0.04) and at 28 days (P=0.03).

Major limitations of the study included the use of open-labeled fluids during allocation, so the initial investigators were not blinded to the type of fluid. Moreover, the study compared two therapeutic strategies (colloid vs. crystalloids) rather than two types of molecules.

Bottom line: In ICU patients with hypovolemia requiring resuscitation, the use of colloids vs. crystalloids did not result in a significant difference in 28-day mortality; however, 90-day mortality was lower among patients receiving colloids.

Citation: Annane D, Siami S, Jaber S, et al. Effects of fluid resuscitation with colloids vs crystalloids on mortality of critically ill patients presenting with hypovolemic shock: the CRISTAL randomization trial. JAMA. 2013;310(17):1809-1817

Clinical question: How does “triple rule out” (TRO) computed tomographic (CT) angiography compare to other imaging modalities in evaluating coronary and other life-threatening etiologies of chest pain, such as pulmonary embolism (PE) and aortic dissection?

Background: TRO CT angiography is a noninvasive technology that evaluates the coronary arteries, thoracic aorta, and pulmonary vasculature simultaneously. Comparison with other tests in the diagnosis of common clinical conditions is useful information for clinical practice.

Study design: Systematic review and meta-analysis.

Setting: Systematic review of 11 studies (one randomized, 10 observational).

Synopsis: Using an enrolled population of 3,539 patients, TRO CT was compared to other imaging modalities on the basis of image quality, diagnostic accuracy, radiation, and contrast volume. When TRO CT was compared to dedicated CT scans, no significant imaging difference was discovered. TRO CT detected CAD with a sensitivity of 94.3% (95% CI, 89.1% to 97.5%, I2=58.2%) and specificity of 97.4% (95% CI, 96.1% to 98.5%, I2=91.2%).

An insufficient number of patients with PE or aortic dissection were studied to generate diagnostic accuracy for these conditions. TRO CT involved greater radiation exposure and contrast exposure than non-TRO CT.

This study reports high accuracy of TRO CT in the diagnosis of coronary artery disease. Due to the low prevalence of patients with PE or aortic dissection (<1%), the data cannot be extrapolated to these conditions.

Bottom line: Although TRO CT is highly accurate for detecting coronary artery disease, there is insufficient data to recommend its use for the diagnosis of PE or aortic dissection.

Citation: Ayaram D, Bellolio MF, Murad MH, et al. Triple rule-out computed tomographic angiography for chest pain: a diagnostic systematic review and meta-analysis. Acad Emerg Med. 2013;20(9):861-871.

Clinical question: How does “triple rule out” (TRO) computed tomographic (CT) angiography compare to other imaging modalities in evaluating coronary and other life-threatening etiologies of chest pain, such as pulmonary embolism (PE) and aortic dissection?

Background: TRO CT angiography is a noninvasive technology that evaluates the coronary arteries, thoracic aorta, and pulmonary vasculature simultaneously. Comparison with other tests in the diagnosis of common clinical conditions is useful information for clinical practice.

Study design: Systematic review and meta-analysis.

Setting: Systematic review of 11 studies (one randomized, 10 observational).

Synopsis: Using an enrolled population of 3,539 patients, TRO CT was compared to other imaging modalities on the basis of image quality, diagnostic accuracy, radiation, and contrast volume. When TRO CT was compared to dedicated CT scans, no significant imaging difference was discovered. TRO CT detected CAD with a sensitivity of 94.3% (95% CI, 89.1% to 97.5%, I2=58.2%) and specificity of 97.4% (95% CI, 96.1% to 98.5%, I2=91.2%).

An insufficient number of patients with PE or aortic dissection were studied to generate diagnostic accuracy for these conditions. TRO CT involved greater radiation exposure and contrast exposure than non-TRO CT.

This study reports high accuracy of TRO CT in the diagnosis of coronary artery disease. Due to the low prevalence of patients with PE or aortic dissection (<1%), the data cannot be extrapolated to these conditions.

Bottom line: Although TRO CT is highly accurate for detecting coronary artery disease, there is insufficient data to recommend its use for the diagnosis of PE or aortic dissection.

Citation: Ayaram D, Bellolio MF, Murad MH, et al. Triple rule-out computed tomographic angiography for chest pain: a diagnostic systematic review and meta-analysis. Acad Emerg Med. 2013;20(9):861-871.

Clinical question: How does “triple rule out” (TRO) computed tomographic (CT) angiography compare to other imaging modalities in evaluating coronary and other life-threatening etiologies of chest pain, such as pulmonary embolism (PE) and aortic dissection?

Background: TRO CT angiography is a noninvasive technology that evaluates the coronary arteries, thoracic aorta, and pulmonary vasculature simultaneously. Comparison with other tests in the diagnosis of common clinical conditions is useful information for clinical practice.

Study design: Systematic review and meta-analysis.

Setting: Systematic review of 11 studies (one randomized, 10 observational).

Synopsis: Using an enrolled population of 3,539 patients, TRO CT was compared to other imaging modalities on the basis of image quality, diagnostic accuracy, radiation, and contrast volume. When TRO CT was compared to dedicated CT scans, no significant imaging difference was discovered. TRO CT detected CAD with a sensitivity of 94.3% (95% CI, 89.1% to 97.5%, I2=58.2%) and specificity of 97.4% (95% CI, 96.1% to 98.5%, I2=91.2%).

An insufficient number of patients with PE or aortic dissection were studied to generate diagnostic accuracy for these conditions. TRO CT involved greater radiation exposure and contrast exposure than non-TRO CT.

This study reports high accuracy of TRO CT in the diagnosis of coronary artery disease. Due to the low prevalence of patients with PE or aortic dissection (<1%), the data cannot be extrapolated to these conditions.

Bottom line: Although TRO CT is highly accurate for detecting coronary artery disease, there is insufficient data to recommend its use for the diagnosis of PE or aortic dissection.

Citation: Ayaram D, Bellolio MF, Murad MH, et al. Triple rule-out computed tomographic angiography for chest pain: a diagnostic systematic review and meta-analysis. Acad Emerg Med. 2013;20(9):861-871.

For cancer patients who have multiple brain metastases, tailoring whole-brain radiotherapy so that it avoids the hippocampus preserves memory and quality of life for at least 6 months, according to a report published online Oct. 27 in the Journal of Clinical Oncology.

Injury to the compartment of neural stem cells located in the subgranular zone of the hippocampal dentate gyrus is thought to suppress the formation of new memory and to impair recall, and injury to this region by relatively low doses of radiotherapy is thought to account for radiation-induced early cognitive decline. Researchers performed a multicenter phase II trial to determine whether sparing this region would prevent such cognitive decline. They assessed 100 patients who had brain metastases of nonhematopoietic malignancies and underwent irradiation of the whole-brain parenchyma minus the “hippocampal avoidance regions” that had been designated using advanced imaging techniques, said Dr. Vinai Gondi of the Cadence Brain Tumor Center and CDH Proton Center, Warrenville, Ill., and his associates.

The study participants underwent cognitive assessment at baseline and at regular intervals following radiotherapy, as well as assessment of health-related quality of life. Their results were compared with those of 208 historical control subjects who had received standard whole-brain radiotherapy without hippocampal avoidance in an unrelated clinical trial. The radiation-sparing technique, which reduced the mean dose to the neural stem compartment by an estimated 80%, produced significant memory preservation that persisted for up to 6 months of follow-up. The mean probability of cognitive deterioration at 4 months was only 7%, compared with 30% in the historical control group.

The hippocampal-sparing technique also preserved physical, social/family, emotional, and functional well-being, as assessed by the patient and his or her family, the investigators said (J. Clin. Oncol. 2014 Oct. 27 [doi:10.1200/JCO.2014.57.2909]).

The risk that metastases would develop in the nonradiated hippocampus was considered low, as only three patients (4.5%) developed such metastases. Previously, investigators have predicted that the risk would be closer to 10%, but they appear to have overestimated the actual risk, Dr. Gondi and his associates said.

These promising results require further validation in phase III trials. Studies are now underway to assess whether further reducing the radiation dose to the hippocampal area may improve outcomes even more, and future studies also are being planned to assess whether hippocampal avoidance prevents longer-term cognitive decline, beyond the 6-month mark established in this study, the investigators added.

This study was supported by the National Cancer Institute’s Radiation Therapy Oncology Group and Community Clinical Oncology Program. Dr. Gondi reported having no financial disclosures; his associates reported numerous ties to industry sources.

For cancer patients who have multiple brain metastases, tailoring whole-brain radiotherapy so that it avoids the hippocampus preserves memory and quality of life for at least 6 months, according to a report published online Oct. 27 in the Journal of Clinical Oncology.

Injury to the compartment of neural stem cells located in the subgranular zone of the hippocampal dentate gyrus is thought to suppress the formation of new memory and to impair recall, and injury to this region by relatively low doses of radiotherapy is thought to account for radiation-induced early cognitive decline. Researchers performed a multicenter phase II trial to determine whether sparing this region would prevent such cognitive decline. They assessed 100 patients who had brain metastases of nonhematopoietic malignancies and underwent irradiation of the whole-brain parenchyma minus the “hippocampal avoidance regions” that had been designated using advanced imaging techniques, said Dr. Vinai Gondi of the Cadence Brain Tumor Center and CDH Proton Center, Warrenville, Ill., and his associates.

The study participants underwent cognitive assessment at baseline and at regular intervals following radiotherapy, as well as assessment of health-related quality of life. Their results were compared with those of 208 historical control subjects who had received standard whole-brain radiotherapy without hippocampal avoidance in an unrelated clinical trial. The radiation-sparing technique, which reduced the mean dose to the neural stem compartment by an estimated 80%, produced significant memory preservation that persisted for up to 6 months of follow-up. The mean probability of cognitive deterioration at 4 months was only 7%, compared with 30% in the historical control group.

The hippocampal-sparing technique also preserved physical, social/family, emotional, and functional well-being, as assessed by the patient and his or her family, the investigators said (J. Clin. Oncol. 2014 Oct. 27 [doi:10.1200/JCO.2014.57.2909]).

The risk that metastases would develop in the nonradiated hippocampus was considered low, as only three patients (4.5%) developed such metastases. Previously, investigators have predicted that the risk would be closer to 10%, but they appear to have overestimated the actual risk, Dr. Gondi and his associates said.

These promising results require further validation in phase III trials. Studies are now underway to assess whether further reducing the radiation dose to the hippocampal area may improve outcomes even more, and future studies also are being planned to assess whether hippocampal avoidance prevents longer-term cognitive decline, beyond the 6-month mark established in this study, the investigators added.

This study was supported by the National Cancer Institute’s Radiation Therapy Oncology Group and Community Clinical Oncology Program. Dr. Gondi reported having no financial disclosures; his associates reported numerous ties to industry sources.

For cancer patients who have multiple brain metastases, tailoring whole-brain radiotherapy so that it avoids the hippocampus preserves memory and quality of life for at least 6 months, according to a report published online Oct. 27 in the Journal of Clinical Oncology.

Injury to the compartment of neural stem cells located in the subgranular zone of the hippocampal dentate gyrus is thought to suppress the formation of new memory and to impair recall, and injury to this region by relatively low doses of radiotherapy is thought to account for radiation-induced early cognitive decline. Researchers performed a multicenter phase II trial to determine whether sparing this region would prevent such cognitive decline. They assessed 100 patients who had brain metastases of nonhematopoietic malignancies and underwent irradiation of the whole-brain parenchyma minus the “hippocampal avoidance regions” that had been designated using advanced imaging techniques, said Dr. Vinai Gondi of the Cadence Brain Tumor Center and CDH Proton Center, Warrenville, Ill., and his associates.

The study participants underwent cognitive assessment at baseline and at regular intervals following radiotherapy, as well as assessment of health-related quality of life. Their results were compared with those of 208 historical control subjects who had received standard whole-brain radiotherapy without hippocampal avoidance in an unrelated clinical trial. The radiation-sparing technique, which reduced the mean dose to the neural stem compartment by an estimated 80%, produced significant memory preservation that persisted for up to 6 months of follow-up. The mean probability of cognitive deterioration at 4 months was only 7%, compared with 30% in the historical control group.

The hippocampal-sparing technique also preserved physical, social/family, emotional, and functional well-being, as assessed by the patient and his or her family, the investigators said (J. Clin. Oncol. 2014 Oct. 27 [doi:10.1200/JCO.2014.57.2909]).

The risk that metastases would develop in the nonradiated hippocampus was considered low, as only three patients (4.5%) developed such metastases. Previously, investigators have predicted that the risk would be closer to 10%, but they appear to have overestimated the actual risk, Dr. Gondi and his associates said.

These promising results require further validation in phase III trials. Studies are now underway to assess whether further reducing the radiation dose to the hippocampal area may improve outcomes even more, and future studies also are being planned to assess whether hippocampal avoidance prevents longer-term cognitive decline, beyond the 6-month mark established in this study, the investigators added.

This study was supported by the National Cancer Institute’s Radiation Therapy Oncology Group and Community Clinical Oncology Program. Dr. Gondi reported having no financial disclosures; his associates reported numerous ties to industry sources.

Clinical question: Do patients who experience overcrowding and long waits in the emergency department (ED) prefer boarding within ED hallways or within inpatient medical unit hallways?

Background: Boarding of admitted patients in EDs can be problematic, especially with regard to patient safety and patient satisfaction. Patient satisfaction data comparing boarding in the ED versus boarding in an inpatient unit hallway is limited.

Study design: Post-discharge, structured, telephone satisfaction survey.

Setting: Suburban, university-based teaching hospital.

Synopsis: A group of patients who experienced hallway boarding in the ED and then hallway boarding on the inpatient medical unit were identified. They were contacted by phone and asked to take a survey on their experience; 105 of 110 patients identified agreed. Patients were asked to rate their location preference with regard to various aspects of care. A five-point Likert scale consisting of the following answers was used: ED hallway much better, ED hallway better, no preference, inpatient hallway better, and inpatient hallway much better.

The inpatient hallway was the overall preferred location in 85% of respondents. Respondents preferred inpatient boarding with regard to multiple other parameters: rest, 85%; safety, 83%; confidentiality, 82%; treatment, 78%; comfort, 79%; quiet, 84%; staff availability, 84%; and privacy, 84%. For no item was there a preference for boarding in the ED.

Patient demographics in this hospital may differ from other settings and should be considered when applying the results. With Hospital Consumer Assessment of Healthcare Providers and Systems scores and ED throughput being publicly reported, further studies in this area would be valuable.

Bottom line: In a post-discharge telephone survey, patients preferred boarding in inpatient unit hallways rather than boarding in the ED.

Citation: Viccellio P, Zito JA, Sayage V, et al. Patients overwhelmingly prefer inpatient boarding to emergency department boarding. J Emerg Med. 2013;45(6):942-946.

Clinical question: Do patients who experience overcrowding and long waits in the emergency department (ED) prefer boarding within ED hallways or within inpatient medical unit hallways?

Background: Boarding of admitted patients in EDs can be problematic, especially with regard to patient safety and patient satisfaction. Patient satisfaction data comparing boarding in the ED versus boarding in an inpatient unit hallway is limited.

Study design: Post-discharge, structured, telephone satisfaction survey.

Setting: Suburban, university-based teaching hospital.

Synopsis: A group of patients who experienced hallway boarding in the ED and then hallway boarding on the inpatient medical unit were identified. They were contacted by phone and asked to take a survey on their experience; 105 of 110 patients identified agreed. Patients were asked to rate their location preference with regard to various aspects of care. A five-point Likert scale consisting of the following answers was used: ED hallway much better, ED hallway better, no preference, inpatient hallway better, and inpatient hallway much better.

The inpatient hallway was the overall preferred location in 85% of respondents. Respondents preferred inpatient boarding with regard to multiple other parameters: rest, 85%; safety, 83%; confidentiality, 82%; treatment, 78%; comfort, 79%; quiet, 84%; staff availability, 84%; and privacy, 84%. For no item was there a preference for boarding in the ED.

Patient demographics in this hospital may differ from other settings and should be considered when applying the results. With Hospital Consumer Assessment of Healthcare Providers and Systems scores and ED throughput being publicly reported, further studies in this area would be valuable.

Bottom line: In a post-discharge telephone survey, patients preferred boarding in inpatient unit hallways rather than boarding in the ED.

Citation: Viccellio P, Zito JA, Sayage V, et al. Patients overwhelmingly prefer inpatient boarding to emergency department boarding. J Emerg Med. 2013;45(6):942-946.

Clinical question: Do patients who experience overcrowding and long waits in the emergency department (ED) prefer boarding within ED hallways or within inpatient medical unit hallways?

Background: Boarding of admitted patients in EDs can be problematic, especially with regard to patient safety and patient satisfaction. Patient satisfaction data comparing boarding in the ED versus boarding in an inpatient unit hallway is limited.

Study design: Post-discharge, structured, telephone satisfaction survey.

Setting: Suburban, university-based teaching hospital.

Synopsis: A group of patients who experienced hallway boarding in the ED and then hallway boarding on the inpatient medical unit were identified. They were contacted by phone and asked to take a survey on their experience; 105 of 110 patients identified agreed. Patients were asked to rate their location preference with regard to various aspects of care. A five-point Likert scale consisting of the following answers was used: ED hallway much better, ED hallway better, no preference, inpatient hallway better, and inpatient hallway much better.

The inpatient hallway was the overall preferred location in 85% of respondents. Respondents preferred inpatient boarding with regard to multiple other parameters: rest, 85%; safety, 83%; confidentiality, 82%; treatment, 78%; comfort, 79%; quiet, 84%; staff availability, 84%; and privacy, 84%. For no item was there a preference for boarding in the ED.

Patient demographics in this hospital may differ from other settings and should be considered when applying the results. With Hospital Consumer Assessment of Healthcare Providers and Systems scores and ED throughput being publicly reported, further studies in this area would be valuable.

Bottom line: In a post-discharge telephone survey, patients preferred boarding in inpatient unit hallways rather than boarding in the ED.

Citation: Viccellio P, Zito JA, Sayage V, et al. Patients overwhelmingly prefer inpatient boarding to emergency department boarding. J Emerg Med. 2013;45(6):942-946.

Clinical question: Does targeted hypothermia (33°C) after cardiac arrest confer benefits compared with targeted temperature management at 36°C?

Background: Therapeutic hypothermia is a current recommendation in resuscitation guidelines after cardiac arrest. Fever develops in many patients after arrest, and it is unclear if the treatment benefit is due to hypothermia or due to the prevention of fever.

Study design: RCT.

Setting: ICUs in Europe and Australia.

Synopsis: The study authors randomized 950 patients who experienced out-of-hospital cardiac arrest to targeted temperature management at either 36°C or 33°C. The goal of this trial was to prevent fever in both groups during the first 36 hours after cardiac arrest. No statistically significant difference in outcomes between these two approaches was found. In the 33°C group, 54% died or had poor neurologic function, compared with 52% in the 36°C group (risk ratio 1.02; 95% CI 0.88 to 1.16; P=0.78).

Given the wide confidence interval, a trial with either more participants or more events might be able to determine whether a true difference in these management approaches exists.

Bottom line: Therapeutic hypothermia at 33°C after out-of-hospital cardiac arrest did not confer a benefit compared with targeted temperature management at 36°C.

Citation: Nielsen N, Wetterslev J, Cronberg T, et al. Targeted temperature management at 33°C versus 36°C after cardiac arrest. N Engl J Med. 2013;369(23):2197-2206.

Clinical question: Does targeted hypothermia (33°C) after cardiac arrest confer benefits compared with targeted temperature management at 36°C?

Background: Therapeutic hypothermia is a current recommendation in resuscitation guidelines after cardiac arrest. Fever develops in many patients after arrest, and it is unclear if the treatment benefit is due to hypothermia or due to the prevention of fever.

Study design: RCT.

Setting: ICUs in Europe and Australia.

Synopsis: The study authors randomized 950 patients who experienced out-of-hospital cardiac arrest to targeted temperature management at either 36°C or 33°C. The goal of this trial was to prevent fever in both groups during the first 36 hours after cardiac arrest. No statistically significant difference in outcomes between these two approaches was found. In the 33°C group, 54% died or had poor neurologic function, compared with 52% in the 36°C group (risk ratio 1.02; 95% CI 0.88 to 1.16; P=0.78).

Given the wide confidence interval, a trial with either more participants or more events might be able to determine whether a true difference in these management approaches exists.

Bottom line: Therapeutic hypothermia at 33°C after out-of-hospital cardiac arrest did not confer a benefit compared with targeted temperature management at 36°C.

Citation: Nielsen N, Wetterslev J, Cronberg T, et al. Targeted temperature management at 33°C versus 36°C after cardiac arrest. N Engl J Med. 2013;369(23):2197-2206.

Clinical question: Does targeted hypothermia (33°C) after cardiac arrest confer benefits compared with targeted temperature management at 36°C?

Background: Therapeutic hypothermia is a current recommendation in resuscitation guidelines after cardiac arrest. Fever develops in many patients after arrest, and it is unclear if the treatment benefit is due to hypothermia or due to the prevention of fever.

Study design: RCT.

Setting: ICUs in Europe and Australia.

Synopsis: The study authors randomized 950 patients who experienced out-of-hospital cardiac arrest to targeted temperature management at either 36°C or 33°C. The goal of this trial was to prevent fever in both groups during the first 36 hours after cardiac arrest. No statistically significant difference in outcomes between these two approaches was found. In the 33°C group, 54% died or had poor neurologic function, compared with 52% in the 36°C group (risk ratio 1.02; 95% CI 0.88 to 1.16; P=0.78).

Given the wide confidence interval, a trial with either more participants or more events might be able to determine whether a true difference in these management approaches exists.

Bottom line: Therapeutic hypothermia at 33°C after out-of-hospital cardiac arrest did not confer a benefit compared with targeted temperature management at 36°C.

Citation: Nielsen N, Wetterslev J, Cronberg T, et al. Targeted temperature management at 33°C versus 36°C after cardiac arrest. N Engl J Med. 2013;369(23):2197-2206.

Clinical question: In patients with ischemic heart disease (IHD) undergoing non-cardiac surgery, do pre-operative beta blockers reduce post-operative major cardiovascular events (MACE) or mortality at 30 days?

Background: Peri-operative beta blocker use has become more restricted, as evidence about which patients derive benefit has become clearer. Opinions and practice vary regarding whether all patients with IHD, or only certain populations within this group, benefit from peri-operative beta blockers.

Study design: Retrospective, national registry-based cohort study.

Setting: Denmark, 2004-2009.

Synopsis: No benefit was found for the overall cohort of 28,263 patients. Patients with IHD and heart failure (n=7990) had lower risk of MACE (HR=0.75, 95% CI, 0.70-0.87) and mortality (HR=0.80, 95% CI, 0.70-0.92). Patients with IHD and myocardial infarction within two years (n=1664) had lower risk of MACE (HR=0.54, 95% CI, 0.37-0.78) but not mortality.

Beta blocker dose and compliance were unknown. Whether patients had symptoms or inducible ischemia was not clear.

This study supports the concept that higher-risk patients benefit more from peri-operative beta blockers, but it is not high-grade evidence.

Bottom line: Not all patients with IHD benefit from pre-operative beta blockers; those with concomitant heart failure or recent MI have a lower risk of MACE and/or mortality at 30 days with beta blockers.

Citation: Andersson C, Merie C, Jorgensen M, et al. Association of ß-blocker therapy with risks of adverse cardiovascular events and deaths in patients with ischemic heart disease undergoing non-cardiac surgery: a Danish nationwide cohort study. JAMA Intern Med. 2014;174(3):336-344.

Clinical question: In patients with ischemic heart disease (IHD) undergoing non-cardiac surgery, do pre-operative beta blockers reduce post-operative major cardiovascular events (MACE) or mortality at 30 days?

Background: Peri-operative beta blocker use has become more restricted, as evidence about which patients derive benefit has become clearer. Opinions and practice vary regarding whether all patients with IHD, or only certain populations within this group, benefit from peri-operative beta blockers.

Study design: Retrospective, national registry-based cohort study.

Setting: Denmark, 2004-2009.

Synopsis: No benefit was found for the overall cohort of 28,263 patients. Patients with IHD and heart failure (n=7990) had lower risk of MACE (HR=0.75, 95% CI, 0.70-0.87) and mortality (HR=0.80, 95% CI, 0.70-0.92). Patients with IHD and myocardial infarction within two years (n=1664) had lower risk of MACE (HR=0.54, 95% CI, 0.37-0.78) but not mortality.

Beta blocker dose and compliance were unknown. Whether patients had symptoms or inducible ischemia was not clear.

This study supports the concept that higher-risk patients benefit more from peri-operative beta blockers, but it is not high-grade evidence.

Bottom line: Not all patients with IHD benefit from pre-operative beta blockers; those with concomitant heart failure or recent MI have a lower risk of MACE and/or mortality at 30 days with beta blockers.

Citation: Andersson C, Merie C, Jorgensen M, et al. Association of ß-blocker therapy with risks of adverse cardiovascular events and deaths in patients with ischemic heart disease undergoing non-cardiac surgery: a Danish nationwide cohort study. JAMA Intern Med. 2014;174(3):336-344.

Clinical question: In patients with ischemic heart disease (IHD) undergoing non-cardiac surgery, do pre-operative beta blockers reduce post-operative major cardiovascular events (MACE) or mortality at 30 days?

Background: Peri-operative beta blocker use has become more restricted, as evidence about which patients derive benefit has become clearer. Opinions and practice vary regarding whether all patients with IHD, or only certain populations within this group, benefit from peri-operative beta blockers.

Study design: Retrospective, national registry-based cohort study.

Setting: Denmark, 2004-2009.

Synopsis: No benefit was found for the overall cohort of 28,263 patients. Patients with IHD and heart failure (n=7990) had lower risk of MACE (HR=0.75, 95% CI, 0.70-0.87) and mortality (HR=0.80, 95% CI, 0.70-0.92). Patients with IHD and myocardial infarction within two years (n=1664) had lower risk of MACE (HR=0.54, 95% CI, 0.37-0.78) but not mortality.

Beta blocker dose and compliance were unknown. Whether patients had symptoms or inducible ischemia was not clear.

This study supports the concept that higher-risk patients benefit more from peri-operative beta blockers, but it is not high-grade evidence.

Bottom line: Not all patients with IHD benefit from pre-operative beta blockers; those with concomitant heart failure or recent MI have a lower risk of MACE and/or mortality at 30 days with beta blockers.

Citation: Andersson C, Merie C, Jorgensen M, et al. Association of ß-blocker therapy with risks of adverse cardiovascular events and deaths in patients with ischemic heart disease undergoing non-cardiac surgery: a Danish nationwide cohort study. JAMA Intern Med. 2014;174(3):336-344.

Clinical question: Do facecards improve patients’ familiarity with physicians and increase satisfaction, trust, and agreement with physicians?

Background: Facecards can improve patients’ knowledge of names and roles of physicians, but their impact on other outcomes is unclear. This pilot trial was designed to assess facecards’ impact on patient satisfaction, trust, or agreement with physicians.

Study design: Cluster, randomized controlled trial (RCT).

Setting: A large teaching hospital in the United States.

Synopsis: Patients (n=138) were randomized to receive either facecards with the name and picture of their hospitalists, as well as a brief description of the hospitalist’s role (n=66), or to receive traditional communication (n=72). There were no significant differences in patient age, sex, or race.

Patients who received a facecard were more likely to correctly identify their hospital physician (89.1% vs. 51.1%; P< 0.01) and were more likely to correctly identify the role of their hospital physician than those in the control group (67.4% vs. 16.3%; P<0.01).

Patients who received a facecard rated satisfaction, trust, and agreement slightly higher compared with those who had not received a card, but the results were not statistically significant (P values 0.27, 0.32, 0.37, respectively.) The authors note that larger studies may be needed to see a difference in these areas.

Bottom line: Facecards improve patients’ knowledge of the names and roles of hospital physicians but have no clear impact on satisfaction with, trust of, or agreement with physicians.

Citation: Simons Y, Caprio T, Furiasse N, Kriss, M, Williams MV, O’Leary KJ. The impact of facecards on patients’ knowledge, satisfaction, trust, and agreement with hospitalist physicians: a pilot study. J Hosp Med. 2014;9(3):137-141.

Clinical question: Do facecards improve patients’ familiarity with physicians and increase satisfaction, trust, and agreement with physicians?

Background: Facecards can improve patients’ knowledge of names and roles of physicians, but their impact on other outcomes is unclear. This pilot trial was designed to assess facecards’ impact on patient satisfaction, trust, or agreement with physicians.

Study design: Cluster, randomized controlled trial (RCT).

Setting: A large teaching hospital in the United States.

Synopsis: Patients (n=138) were randomized to receive either facecards with the name and picture of their hospitalists, as well as a brief description of the hospitalist’s role (n=66), or to receive traditional communication (n=72). There were no significant differences in patient age, sex, or race.

Patients who received a facecard were more likely to correctly identify their hospital physician (89.1% vs. 51.1%; P< 0.01) and were more likely to correctly identify the role of their hospital physician than those in the control group (67.4% vs. 16.3%; P<0.01).

Patients who received a facecard rated satisfaction, trust, and agreement slightly higher compared with those who had not received a card, but the results were not statistically significant (P values 0.27, 0.32, 0.37, respectively.) The authors note that larger studies may be needed to see a difference in these areas.

Bottom line: Facecards improve patients’ knowledge of the names and roles of hospital physicians but have no clear impact on satisfaction with, trust of, or agreement with physicians.

Citation: Simons Y, Caprio T, Furiasse N, Kriss, M, Williams MV, O’Leary KJ. The impact of facecards on patients’ knowledge, satisfaction, trust, and agreement with hospitalist physicians: a pilot study. J Hosp Med. 2014;9(3):137-141.

Clinical question: Do facecards improve patients’ familiarity with physicians and increase satisfaction, trust, and agreement with physicians?

Background: Facecards can improve patients’ knowledge of names and roles of physicians, but their impact on other outcomes is unclear. This pilot trial was designed to assess facecards’ impact on patient satisfaction, trust, or agreement with physicians.

Study design: Cluster, randomized controlled trial (RCT).

Setting: A large teaching hospital in the United States.

Synopsis: Patients (n=138) were randomized to receive either facecards with the name and picture of their hospitalists, as well as a brief description of the hospitalist’s role (n=66), or to receive traditional communication (n=72). There were no significant differences in patient age, sex, or race.

Patients who received a facecard were more likely to correctly identify their hospital physician (89.1% vs. 51.1%; P< 0.01) and were more likely to correctly identify the role of their hospital physician than those in the control group (67.4% vs. 16.3%; P<0.01).

Patients who received a facecard rated satisfaction, trust, and agreement slightly higher compared with those who had not received a card, but the results were not statistically significant (P values 0.27, 0.32, 0.37, respectively.) The authors note that larger studies may be needed to see a difference in these areas.

Bottom line: Facecards improve patients’ knowledge of the names and roles of hospital physicians but have no clear impact on satisfaction with, trust of, or agreement with physicians.

Citation: Simons Y, Caprio T, Furiasse N, Kriss, M, Williams MV, O’Leary KJ. The impact of facecards on patients’ knowledge, satisfaction, trust, and agreement with hospitalist physicians: a pilot study. J Hosp Med. 2014;9(3):137-141.

Clinical question: Is there a difference in efficacy and safety among new oral anticoagulants compared to warfarin in subgroups of patients with atrial fibrillation (Afib)?

Background: Studies of new oral anticoagulants have demonstrated that these agents are at least as safe and effective as warfarin for prevention of stroke and systemic embolism in Afib. This study was designed to look at available phase 3 randomized trials, with the goal of subgroup analysis for both efficacy and bleeding risks.

Study design: Meta-analysis.

Setting: Phase 3 randomized controlled trials of patients with Afib.

Synopsis: The analysis included four trials of Afib patients randomized to receive warfarin or a novel oral anticoagulant (NOAC), including dabigatran, rivaroxaban, apixaban, and edoxaban. In total, 42,411 patients received an NOAC and 29,272 patients received warfarin. Separate analyses were performed for high-dose and low-dose NOACs.

The high-dose NOAC demonstrated a 19% reduction in stroke and systemic embolic events as compared to warfarin, largely due to the reduction of hemorrhagic strokes by the NOAC. The low-dose NOAC showed similar efficacy to warfarin for reduction of stroke and systemic embolic events, with an increase noted in the subset of ischemic stroke in low-dose NOAC. Both doses of NOAC demonstrated a significant reduction in all-cause mortality. NOAC showed a non-significant reduction in bleeding compared to warfarin; however, subset analysis demonstrated an increase in gastrointestinal bleeding with high-dose NOAC and a significant reduction in intracranial hemorrhage with low-dose NOAC.

A notable limitation of the study is that it only included clinical trials in the analysis.

Bottom line: In relation to stroke, systemic embolic events, and all-cause mortality, new oral anticoagulants showed a favorable efficacy and safety profile as compared to warfarin in Afib patients.

Citation: Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955-962.

Clinical question: Is there a difference in efficacy and safety among new oral anticoagulants compared to warfarin in subgroups of patients with atrial fibrillation (Afib)?

Background: Studies of new oral anticoagulants have demonstrated that these agents are at least as safe and effective as warfarin for prevention of stroke and systemic embolism in Afib. This study was designed to look at available phase 3 randomized trials, with the goal of subgroup analysis for both efficacy and bleeding risks.

Study design: Meta-analysis.

Setting: Phase 3 randomized controlled trials of patients with Afib.

Synopsis: The analysis included four trials of Afib patients randomized to receive warfarin or a novel oral anticoagulant (NOAC), including dabigatran, rivaroxaban, apixaban, and edoxaban. In total, 42,411 patients received an NOAC and 29,272 patients received warfarin. Separate analyses were performed for high-dose and low-dose NOACs.

The high-dose NOAC demonstrated a 19% reduction in stroke and systemic embolic events as compared to warfarin, largely due to the reduction of hemorrhagic strokes by the NOAC. The low-dose NOAC showed similar efficacy to warfarin for reduction of stroke and systemic embolic events, with an increase noted in the subset of ischemic stroke in low-dose NOAC. Both doses of NOAC demonstrated a significant reduction in all-cause mortality. NOAC showed a non-significant reduction in bleeding compared to warfarin; however, subset analysis demonstrated an increase in gastrointestinal bleeding with high-dose NOAC and a significant reduction in intracranial hemorrhage with low-dose NOAC.

A notable limitation of the study is that it only included clinical trials in the analysis.

Bottom line: In relation to stroke, systemic embolic events, and all-cause mortality, new oral anticoagulants showed a favorable efficacy and safety profile as compared to warfarin in Afib patients.

Citation: Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955-962.

Clinical question: Is there a difference in efficacy and safety among new oral anticoagulants compared to warfarin in subgroups of patients with atrial fibrillation (Afib)?

Background: Studies of new oral anticoagulants have demonstrated that these agents are at least as safe and effective as warfarin for prevention of stroke and systemic embolism in Afib. This study was designed to look at available phase 3 randomized trials, with the goal of subgroup analysis for both efficacy and bleeding risks.

Study design: Meta-analysis.

Setting: Phase 3 randomized controlled trials of patients with Afib.

Synopsis: The analysis included four trials of Afib patients randomized to receive warfarin or a novel oral anticoagulant (NOAC), including dabigatran, rivaroxaban, apixaban, and edoxaban. In total, 42,411 patients received an NOAC and 29,272 patients received warfarin. Separate analyses were performed for high-dose and low-dose NOACs.

The high-dose NOAC demonstrated a 19% reduction in stroke and systemic embolic events as compared to warfarin, largely due to the reduction of hemorrhagic strokes by the NOAC. The low-dose NOAC showed similar efficacy to warfarin for reduction of stroke and systemic embolic events, with an increase noted in the subset of ischemic stroke in low-dose NOAC. Both doses of NOAC demonstrated a significant reduction in all-cause mortality. NOAC showed a non-significant reduction in bleeding compared to warfarin; however, subset analysis demonstrated an increase in gastrointestinal bleeding with high-dose NOAC and a significant reduction in intracranial hemorrhage with low-dose NOAC.

A notable limitation of the study is that it only included clinical trials in the analysis.

Bottom line: In relation to stroke, systemic embolic events, and all-cause mortality, new oral anticoagulants showed a favorable efficacy and safety profile as compared to warfarin in Afib patients.

Citation: Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955-962.